Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

• have not received any prior systemic anti-myeloma therapy AND

• have measurable disease AND

• are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

• Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

• Monoclonal Gammopathy of Undetermined Significance (MGUS)

• Active plasma cell leukemia

• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C